ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

EP-TRIPLE

Study hypothesis

A triple combination of non-opioid drugs (i.e. acetaminophen, meloxicam and gabapentin) will reduce post-surgical evoked pain to a greater degree than any of the three respective double-drug combinations (i.e. meloxicam, acetaminophen and gabapentin is superior to meloxicam and acetaminophen, meloxicam and gabapentin and acetaminophen and gabapentin).

Ethics approval

Queen's University Research Ethics Board, 02/11/2009

Study design

Double-blind randomised controlled parallel-design four-arm trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Total duration of treatment is from one hour before surgery to 48 hours after surgery. Total duration of follow-up is 30 days following surgery for all trial arms.

Intervention type

Drug

Phase

Phase IV

Drug names

Meloxicam, acetaminophen, gabapentin

Primary outcome measures

Cough-evoked pain intensity, recorded on the day of surgery and post-operative days one and two.

Secondary outcome measures

1. Pain intensity at rest, during sitting, and with forced expiration2. Retrospective measure of average nocturnal pain intensity from 10 pm (previous day) to 8 am (current morning) recorded at 8 am on post-operative days 1 and 23. Peak expiratory flow rate, forced vital capacity, forced expiratory volume over one second4. Total opioid consumption (fentanyl on day of surgery, morphine [nurse-administered and patient-controlled] on day of surgery and post-operative days 1 and 2)5. Time to fulfilment of post-anaesthetic care unit discharge criteria6. Presence and severity (mild, moderate or severe) of 12 opioid-related symptoms (evaluated by open-ended questioning): nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness or difficulty staying awake, feeling light-headed or dizzy, feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache7. Other side effects and their severity (mild, moderate or severe)8. Time to bladder extubation; time to first urination after bladder catheter removal; time to first bowel movement9. Timed 'up and go' test10. Blinding questionnaires11. Modified Brief Pain Inventory12. Time to discharge from hospital, time to return to regular activities and return to work (in those working outside of the home)13. 30-day post-operative surgical pain intensity (present rest pain, present cough pain and worst pain in past week)

Recorded on the day of surgery and post-operative days one and two. On post-operative day 30, only pain and major adverse events will be recorded.